Cleared Special

K152861 - Aquasil Ultra + Smart Wetting Impression Material (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K152861 · Dentply International, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2016
Decision
156d
Days
Class 2
Risk

K152861 is an FDA 510(k) clearance for the Aquasil Ultra + Smart Wetting Impression Material. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Dentply International, Inc. (York, US). The FDA issued a Cleared decision on March 4, 2016 after a review of 156 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Dentply International, Inc. devices

Submission Details

510(k) Number K152861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2015
Decision Date March 04, 2016
Days to Decision 156 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 127d · This submission: 156d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 401
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K152861.
Dia-X Sil Bite
K254112 · DiaDent Group International · Mar 2026
Hydro Print Premium Fast Set - 454g (1lb) (052037)
K253501 · Vigodent Ind?stria E Comercio Ltda · Oct 2025
JET BITE
K250969 · Dent4you AG · Jun 2025
Elastic Impression Material
K241924 · Beijing Okvd Biological Technology , Ltd. · Dec 2024
Speedex Light Body
K242360 · Dent4you AG · Nov 2024
Chemi-SiL (HB, MB, LB, LBS)
K233954 · B&E Korea Co., Ltd. · Feb 2024